1. Field of the Invention
The present invention is directed to vaginal tablets comprising misoprostol and a pharmaceutically acceptable pH insensitive, hydrophilic cellulose material, wherein the vaginal tablets do not contain a hydrophobic release controlling agent, and wherein the misoprostol and the pharmaceutically acceptable pH insensitive, hydrophilic cellulose material are in a ratio of about 1:50 to about 1:800, and wherein the vaginal tablets do not substantially change the pH of a vaginal tract.
2. Background Art
Pharmaceutical products have been traditionally administered via an oral, pulmonary or subcutaneous routes. However, for many pharmaceutical products, vaginal administration is a preferred route. Vaginal administration can be preferred since it allows active agents to quickly enter the bloodstream. Additionally, vaginal administration allows an active agent to avoid first pass hepatic degradation. In some instances, an active agent acts locally in the vaginal tract, and thus vaginal administration can avoid any side effects associated with systemic administration.
Misoprostol is a synthetic prostaglandin E1 chemical derivative, used to prevent ulcers in people who take certain arthritis or pain medicines, including aspirin, that can cause ulcers. Misoprostol protects the stomach lining and decreases stomach acid secretion. Additionally, misoprostol has been shown to induce uterine contractions and to promote the softening of the cervix.
The common mode of adminstration of misoprostol is via oral tablets. For example, the commercial product Cytotec® (GD Searle & Co., Skokie, Ill.) is an oral tablet containing 100 μg or 200 μg of misoprostol. Misoprostol is known to degrade to a prostaglandin in the presence of water. Thus, commercial misoprostol oral tablets often contain hydrophobic excipients.
There exists a need in the art for a vaginial tablet comprising misoprostol which promotes the stability of misoprostol while still achieving the desired release rate.